NCT07185035招募中1 期
An Exploratory Clinical Study on the Safety and Efficacy of Autologous NK Cells in the Treatment of Pulmonary Nodules
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年9月20日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of all adverse events occurring within 28 days after the first infusion of KN5001
研究概览
简要总结
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily sign the informed consent form, understand this clinical study, and are willing to follow and able to complete all trial procedures;
- •18-70 years old, male or female;
- •Subjects with lung nodules confirmed by imaging examination must meet the following conditions:
- •Multiple high-risk nodules have been surgically removed and confirmed to be malignant lesions, and the remaining high-risk nodules (refer to the standards in Appendix 12) cannot be surgically removed again, and are not suitable for other effective treatments or have failed other treatments;
- •If the subject is unable to complete the puncture or the puncture fails, the subject must be diagnosed as a malignant nodule through PET-CT imaging examination.
排除标准
- •Subjects who are known to have allergic reactions, hypersensitivity reactions, intolerances or contraindications to any component of KN5001, or subjects with a history of severe allergic reactions;
- •Subjects with the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known bone marrow failure syndrome;
- •Subjects with active or uncontrolled infections requiring parenteral antibiotics; Evidence of a serious active viral or bacterial infection or an uncontrolled systemic fungal infection;
- •Subjects with heart failure of grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standard (see Appendix 1);
- •Subjects with a history of epilepsy or other central nervous system diseases;
- •Subjects with a history of malignant tumors, excluding patients with cured skin or cervical carcinoma in situ and patients with inactive tumors;
- •Subjects with a significant bleeding tendency, such as gastrointestinal bleeding, coagulopathy, hypersplenism, etc.;
- •Subjects with unstable angina, symptomatic congestive heart failure, or myocardial infarction in the past 6 months;
- •Females who are pregnant, lactating, or planning a pregnancy within six months;
- •Subjects who have received other clinical trial treatment within 3 months;
- •Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.
研究组 & 干预措施
KN5001
Experimental
干预措施: KN5001 (Biological)
结局指标
主要结局
Incidence of all adverse events occurring within 28 days after the first infusion of KN5001
时间窗: Time Frame: up to 28 days after infusion
To characterize the Treatment Emergent Adverse Events (TEAEs) of KN5001 for patients with pulmonary nodules
次要结局
- Disease control rate (DCR)(Time Frame: 6 and 12 months after infusion)
- The overall response rate (ORR)(Time Frame: 6 and 12 months after infusion)
研究者
研究点 (1)
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